EVIS EXERA lll GASTROINTESTINAL VIDEOSCOPERecalls & reported problems across all models
Olympus Medical Systems Corp. · 2 models in the FDA device registry
Data updated Oct 18, 2026 from official FDA records · Editorial policy
1 open recall names at least one EVIS EXERA lll GASTROINTESTINAL VIDEOSCOPE model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 587
- Deaths reported
- 0
- Injuries reported
- 7
- Recalls
- 1
We found 2 models of EVIS EXERA lll GASTROINTESTINAL VIDEOSCOPE by Olympus Medical Systems Corp. in the FDA's device registry (GUDID). Together they are named in 587 adverse event reports in the FDA's MAUDE database, received between Jan 15, 2019 and Sep 28, 2026 — classified as 7 injuries, 580 malfunctions.
The most frequently reported specific device problem is “Failure to Clean Adequately” (221 reports).
1 FDA recall record name at least one of these models by its device identifier, 1 still open.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
EVIS EXERA lll GASTROINTESTINAL VIDEOSCOPE recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- Sep 25, 2023Class IIOpen, Classified
Channel air drying process was not validated, and that a small percentage of scopes returned to customers after repair had a wet channel. Water remaining in the channel of the endoscopes has the potential for contamination that could lead to the risk of infection
Z-0334-2024 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
Most reported EVIS EXERA lll GASTROINTESTINAL VIDEOSCOPE problems
Device problems
- Failure to Clean Adequately221
- Device Reprocessing Problem66
- No Display/Image62
- Communication or Transmission Problem60
- Microbial Contamination of Device50
- Poor Quality Image50
- Residue After Decontamination26
- Overheating of Device13
Patient problems
- No Clinical Signs, Symptoms or Conditions561
- No Known Impact Or Consequence To Patient9
- No Consequences Or Impact To Patient7
- Insufficient Information3
- Sepsis3
- Cancer1
- Foreign Body In Patient1
- No Patient Involvement1
EVIS EXERA lll GASTROINTESTINAL VIDEOSCOPE models
2 models, most reported first. Each model has its own page with its reports, recalls and device details.
- EVIS EXERA lll GASTROINTESTINAL VIDEOSCOPE OLYMPUS GIF-XP190NGastroscope and accessories, flexible/rigid1 recall559 reports
- EVIS EXERA lll GASTROINTESTINAL VIDEOSCOPE OLYMPUS GIF-XP190NGastroscope And Accessories, Flexible/Rigid28 reports
Recent EVIS EXERA lll GASTROINTESTINAL VIDEOSCOPE adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionSep 28, 2026Failure to Clean Adequately
The customer returned the Gastrointestinal Videoscope to the service center for a separate issue. During device analysis, the service technician identified that the device had white foreign material in the air/water channel and cylinder. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50919008 ↗MalfunctionSep 28, 2026No Display/Image
It was reported that the image of the Gastrointestinal Videoscope was not working. The issue occurred during reprocessing. There was no patient involvement. During initial device inspection, it was found that the image was black.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50915309 ↗MalfunctionSep 28, 2026Device Reprocessing Problem
The customer returned the Gastrointestinal Videoscope to the service center for a separate issue. During device analysis, the service technician identified that the device had black foreign material in the air/water nozzle and white foreign material in the air/water channel and cylinder. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50915290 ↗MalfunctionSep 23, 2026Communication or Transmission Problem
The customer returned the gastrointestinal videoscope for a separate issue. During the initial inspection of the device, error E216 scope communication error was found. No patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50867815 ↗MalfunctionSep 23, 2026Display or Visual Feedback Problem
The customer returned the Gastrointestinal Videoscope for a separate issue. During inspection of the device, it was found that the screen was black with no image displayed. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50863152 ↗MalfunctionSep 23, 2026Device Reprocessing Problem; Optical Problem
No additional information received from the customer.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50863137 ↗MalfunctionSep 23, 2026Poor Quality Image
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50863028 ↗MalfunctionSep 22, 2026Poor Quality Image
The customer returned the Gastrointestinal Videoscope to the service center for evaluation related to a separate issue. During device analysis, the Service Repair Technician identified that the device exhibited a blurry image. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50852434 ↗MalfunctionSep 10, 2026Residue After Decontamination; Failure to Clean Adequately
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50724892 ↗MalfunctionSep 3, 2026Failure to Clean Adequately
No additional information received from the customer.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50596576 ↗MalfunctionAug 28, 2026Communication or Transmission Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50509714 ↗MalfunctionAug 19, 2026Device Reprocessing Problem; Erratic or Intermittent Display; No Display/Image
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50330308 ↗MalfunctionAug 18, 2026Residue After Decontamination
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50307485 ↗MalfunctionJul 14, 2026No Display/Image
THE CUSTOMER RETURNED THE GASTROINTESTINAL VIDEOSCOPE TO THE SERVICE CENTER FOR EVALUATION FOR A SEPARATE ISSUE. DURING TESTING, THE SERVICE REPAIR TECHNICIAN IDENTIFIED THAT THE DEVICE HAD A BLACKOUT AND NO IMAGE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25820281 ↗MalfunctionJul 14, 2026Contamination
THE CUSTOMER RETURNED THE GASTROINTESTINAL VIDEOSCOPE TO THE SERVICE CENTER FOR EVALUATION FOR A SEPARATE ISSUE. DURING TESTING, THE SERVICE REPAIR TECHNICIAN IDENTIFIED THAT THE DEVICE HAD A CLOGGED NOZZLE WITH BLACK DEBRIS. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25817988 ↗
Other Olympus Medical Systems Corp. products
- EVIS EXERA lll COLONOVIDEOSCOPE16 models · 15,013 reports · 7 recalls
- EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE7 models · 13,448 reports · 7 recalls
- EVIS EXERA II ULTRASOUND GASTROVIDEOSCOPE9 models · 8,317 reports · 2 recalls
- EVIS EXERA III BRONCHOVIDEOSCOPE11 models · 6,060 reports · 16 recalls
- EVIS EXERA III XENON LIGHT SOURCE2 models · 6,694 reports
- EVIS EXERA III COLONOVIDEOSCOPE6 models · 6,117 reports · 5 recalls
- EVIS EXERA III DUODENOVIDEOSCOPE OLYMPUS TJF-Q190V2 models · 5,281 reports · 4 recalls
- HD CAMERA HEAD2 models · 5,217 reports
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page